- Coordinate validation and qualification activities for a manufacturing company.
- Maintain quality documentation and manage document control processes.
- Support compliance projects and develop SOPs in a regulated environment.
Your new company
Join an established manufacturer operating across the complementary medicine and food sectors. With quality and compliance central to its operations, the business is seeking a Validation & Quality Systems Specialist to support its site-based validation program and maintain clear, practical and compliant quality documentation.
Your new role
Reporting to the Senior Quality Assurance Manager, you will coordinate validation and qualification activities while taking day-to-day ownership of document control, SOP development and controlled quality documentation.
Your responsibilities will include:
- Coordinating and maintaining the site's Validation Master Plan, schedules and registers
- Supporting equipment qualification, including IQ, OQ and PQ activities
- Preparing and reviewing validation protocols, reports and risk assessments
- Coordinating process and cleaning validation activities
- Maintaining equipment qualification and validation lifecycle documentation
- Assessing validation and document-control requirements arising from change controls
- Managing controlled documents, version control, reviews, approvals and archiving
- Drafting and updating SOPs, work instructions, forms, templates and checklists
- Supporting validation-related deviations, investigations and CAPAs
- Working closely with Quality, Operations, Engineering and Production teams
- Progressively developing capability in batch-document review, product disposition and Release for Supply processes
The position may also support activities such as computerised-system validation, temperature mapping, method validation or verification, facility and utility qualification, and new-product introduction.
What you'll need to succeed
You will have:
- A relevant qualification in science, engineering, quality, pharmaceutical manufacturing, food science or a related discipline
- Experience within a manufacturing, quality, technical, validation or engineering environment
- Strong technical writing skills, with the ability to produce clear and practical SOPs
- Excellent attention to detail and document-management capability
- Strong organisational skills and the ability to manage competing priorities
- Confidence working across multiple operational and technical teams
Experience in validation, equipment qualification, GMP-regulated manufacturing, controlled-document systems or batch documentation will be highly regarded. Exposure to TGA or PIC/S GMP requirements would also be beneficial.
What you'll get in return
This is an opportunity to take ownership of key validation and quality-system activities within a regulated manufacturing environment. You will work across a varied portfolio of validation, documentation and compliance projects while building broader capability in GMP, batch review and product disposition.
For the right person, the role offers a structured pathway to develop additional quality responsibilities, with future progression based on demonstrated experience, competency and business requirements.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV to courtney.ham@hays.com.au, or call Courtney Ham on -2 8763 5632.
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